Quality Engineer

Location: Humacao, Puerto Rico, Puerto Rico
Date Posted: 12-06-2016
Description
The successful candidate must have experience in Quality Engineering areas for regulated environment industries such as Medical Device, Pharmaceutical, Bio-pharmaceutical or other FDA regulated industry.
 
Duties and responsibilities 
Provide support and technical expertise to collaborate and support Quality Engineering Lead projects. Assist in the management of the Quality System, Product & Process Design and Controls and Supply Quality Management. Knowledge and application of Quality Assurance and Regulatory Requirements and change management.  Analyzes quality data and identifies trends impacting risk benefits requirements of product and quality systems with primary responsibility for the maintenance of raw material suppliers (SPC, DOE, etc). Provides recommendations or proposed changes based on data analysis. Support the inspection methods. Ability to effectively utilize key knowledge of business processes, analytical tools and the regulatory environment in support of the supplier quality management of purchasing controls.

Education
  • Bachelor Degree in Engineering field.
  • 2-5 year of experience related to Quality Engineering in the FDA regulated environment. 
Skills & Requirements
  • Quality Engineering
  • Statistical Knowledge (SPC, DOE, CPk)
  • Validation
  • Medical Devices or pharmaceutical experience.
  • Project Engineeringt skills 
  • Inspection methods
  • Bilingual (English & Spanish).
     
Ultimate Solutions Corp. is an Equal Opportunity Employer.
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